Nicox NCX 470 NDA Accepted for Review With April 30, 2027 PDUFA Target Action Date
Nicox SA (Euronext: COX) announced Wednesday August 26, 2026 that the FDA accepted the New Drug Application for NCX 470 (bimatoprost-nitric oxide donor, a once-daily topical eye drop for the reduction of intraocular pressure in open-angle glaucoma or ocular hypertension) with a PDUFA target action date of April 30, 2027. NCX 470 combines the FDA-approved prostaglandin analog bimatoprost with a nitric-oxide-releasing moiety intended to add trabecular meshwork outflow to the standard uveoscleral outflow mechanism, and completed two positive Phase 3 studies (Mont Blanc and Denali). Not a peptide, but the readout matters as ophthalmology continues to be a Phase 3 register hub for peptide programs (Palatin's PL9643 melanocortin-4 receptor agonist for dry eye) that would follow the same combination-with-standard-of-care commercial pattern if approved.